IP Library Granted Patent US 44,159
Granted Patent E1
US 44,159 · App. 11/892,969 · Granted Apr 16, 2013

Composition for contraception

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Quick Facts
Patent No.
US 44,159
App. No.
11/892,969
Granted
Apr 16, 2013
Kind
E1
Abstract

A combination product for oral contraception is disclosed comprising an estrogen selected from 2.0 to 6.0 mg of 17β-estradiol and 0.020 mg of ethinylestradiol; and a gestagen selected from 0.25 to 0.30 mg of drospirenone and 0.1 to 0.2 mg of cyproterone acetate, followed by 5 or 4 pill-free or sugar pill days.

Claims (36)

1. A combination product for oral contraception, comprising

(a) 23 or 24 dosage units, each containing an estrogen selected from

>2.0 to 6.0 mg of 17β-estradiol and

0.020 mg of ethinylestradiol;

and a gestagen selected from

0.25 to 0.30 mg of drospirenone and

0.1 to 0.2 mg of cyproterone acetate,

and

b) 5 or 4, respectively, active ingredient-free placebo pills or other indications to show that the daily administration of the 23 or 24 dosage units respectively, is to be followed by 5 or 4, respectively pill-free or placebo pill days.

2. A combination preparation for oral contraception according to claim 1 , wherein the estrogen is ethinylestradiol.

3. A combination preparation of claim 2 , wherein the gestagen is cyproterone acetate.

4. A combination preparation of claim 2 , wherein the gestagen is drospirenone.

5. A combination preparation according to claim 1 , wherein the estrogen is present in a dose of 20 μg of ethinylestradiol or an equivalent dose of 17β-estradiol and the gestagen is present in a dose equivalent to 75 μg of gestadene.

6. A combination preparation according to claim 1 , which comprises 23 dosage units and 5 placebo pills or other indications to show that no dosage unit or a placebo pill is administered during the last 5 days of the menstrual cycle.

7. A combination preparation according to claim 1 , which comprises 23 dosage units, each containing 20 μg of ethinylestradiol and a dose of cyproterone acetate or drospirenone equivalent to 75 μg of gestodene and 5 placebo pills or other indications to show that no dosage unit or a placebo pill is administered during the last 5 days of the menstrual cycle.

8. A combination preparation of claim 1 , wherein the estrogen is 17β-estradiol.

9. A combination preparation of claim 8 , wherein the gestagen is cyproterone acetate.

10. A combination preparation of claim 8 , wherein the gestagen is drospirenone.

11. A method of inducing contraception in a female of reproductive age who has not yet reached premenopause, comprising administering to said female a monophasic composition that effectively lessens premenstrual syndrome, comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

12. A method of claim 11 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg.

13. A method of claim 12 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

14. A method of inducing contraception in a female of reproductive age who has not yet reached premenopause, comprising administering to said female a monophasic composition that effectively lessens breast tenderness, comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition effectively lessens breast tenderness, and is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

15. A method of claim 14 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg.

16. A method of claim 15 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

17. A method of claim 11 wherein the composition effectively lessens breast tenderness.

18. A method of claim 17 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg.

19. A method of claim 18 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

20. A method of inducing contraception in a female of reproductive age suffering from premenstrual syndrome who has not yet reached premenopause, comprising administering to said female a monophasic composition comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

21. A method of claim 20 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg.

22. A method of claim 21 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

23. A method of inducing contraception in a female of reproductive age suffering from breast tenderness who has not yet reached premenopause, comprising administering to said female a monophasic composition comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

24. A method of claim 23 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg.

25. A method of claim 24 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.

26. A method of claim 20 wherein the female of reproductive age suffers from breast tenderness.

27. A method of claim 26 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg.

28. A method of claim 27 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.